title: Profermin is efficacious in patients with active ulcerative colitis--a randomized controlled trial.
abstract: BACKGROUND
  Profermin is developed for the dietary management of ulcerative colitis (UC). It consists of water, fermented oats, barley malt, lecithin, and Lactobacillus plantarum 299v. The aim of this study was to assess the clinical efficacy of Profermin.
  
  
  METHODS
  Seventy-four patients with a mild-to-moderate flare-up of UC (defined as Simple Clinical Colitis Activity Index [SCCAI] score ≥5 and ≤11) were randomly assigned to Profermin (n = 32) or Fresubin (n = 41). The primary endpoint was to assess whether addition of Profermin in UC could significantly reduce SCCAI in comparison with Fresubin.
  
  
  RESULTS
  In the run-in period, the mean SCCAI was 7.2 ± 1.50 in the Profermin group and 7.6 ± 1.47 in the Fresubin group (not significant). After 8 weeks of treatment, the mean reduction of SCCAI score was higher in the Profermin group (mean difference: -1.77 SCCAI, 95% confidence interval -2.97 to -0.55; P < 0.005), in intention-to-treat analyses. Remission defined as SCCAI ≤2.5 was achieved in 10 of 32 (31%) in the Profermin group and in 6 of 41 (15%) in the Fresubin group (P = 0.048). The decrease in SCCAI scores of ≥50% was higher in the Profermin group 17 of 32 (53%) versus 11 of 41 (27%) (P = 0.04). The risk of dropping out due to treatment failure/lack of effect was higher in the Fresubin group (42% versus 13%, P = 0.02).
  
  
  CONCLUSIONS
  Supplementation with Profermin is safe, well tolerated, palatable, and able to reduce SCCAI scores at a statistically and clinically significant level in patients with mild-to-moderate UC with a flare-up.
authors.affiliation: *Department of Gastroenterology, Odense University Hospital, Odense, Denmark; †Gastroenterology Unit, Medical Section, Herlev University Hospital, Copenhagen, Denmark; ‡Nordisk Rebalance, Allerød, Denmark; §Statistics, Bioinformatics and Registry, Danish Cancer Society Research Center, Copenhagen, Denmark; and ‖Gastrounit, Medical Division, Hvidovre University Hospital, Denmark.
authors.forename: Aleksander
authors.initials: A
authors.lastname: Krag
authors.forename: Pia
authors.initials: P
authors.lastname: Munkholm
authors.forename: Hans
authors.initials: H
authors.lastname: Israelsen
authors.forename: Bjørn
authors.initials: B
authors.lastname: von Ryberg
authors.forename: Klaus K
authors.initials: KK
authors.lastname: Andersen
authors.forename: Flemming
authors.initials: F
authors.lastname: Bendtsen
mesh_terms: D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000178:diet therapy*; D045424:Complex Mixtures / Q000627:therapeutic use*; D019587:Dietary Supplements; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012074:Remission Induction; D055815:Young Adult
chemical_list: D045424:Complex Mixtures; C574856:profermin